The words qualification and validation are used interchangeably in the cold chain industry especially pharma industry. However, there are slight differences between the two. We are trying to explain the difference in this article.

What is a qualification of an asset used in pharma?

Basically, temperature qualification is on equipment or assets used to store medicines, vaccines etc. This involves temperature mapping study, design qualification, performance qualification, operation qualification etc. Please see our detailed page on Temperature qualification study for more details. We carry out a qualification study to prove that the particular asset is good enough to store the medicine.
Eg. Temperature qualification is applicable for assets such as a medicine cold room to certify that it is good for storing the medicines between 2 to 8°C under all operational conditions within the cold room.

What is validation?

The validation is done for methods and processes. A process involves multiple steps possible involving multiple assets as well. It can be for a process within the same asset as well. Please see few example below for better understanding.

Temperature validation of delivery process of a medicine.

Validation is for a method or process such as complete delivery of a medicine. Eg. If you want to validate the process of a medicine distribution, you have to start the complete testing process from the moment of packing from the cold room, moving it through your warehouse, loading it onto a van, van travels to a particular destination for certain hours, a person carries it to the customer etc. This validates that your entire process is good and the medicine is not affected. If a temperature validation is done for this process, it means that the method you tested is good enough to keep the quality of the medicines.
In the process, all the assets used for delivery such as the box, the van etc. have to be qualified as well.

Validation of despatch process of a medicine through air

Suppose you regularly despatch medicine through the air to another country. This involves a lot of movement of the goods through various procedures. From your warehouse onwards it changes many hands, many temperature conditions, many types of vehicles etc. You need to make sure that the medicine you despatch from your warehouse reaches in good condition at another country. You might be trying to validate despatch through different flight routes. Once you validate, you will see the best selection.

Validation of a software for a monitoring system

Validation is also applicable for software of a monitoring system to prove that the software is delivering the data correctly. In the case of a monitoring system, there are many components starting from a sensor, and different software and hardware interfaces. All of them have to work perfectly until the report reaches you. This is software validation. Otherwise, you have no guarantee that what the display unit shows in the cold room is same as that you see in the software. It is possible that there will be errors since the data is passing through entirely different platforms. For validation of electronic measuring instruments, there is a standard issued by the Federal Government of the USA. The relevant standards for such monitoring system are 21 CFR Part 11. Please read more on 21 CFR Part 11 at this page.

Validation of packing method inside a cold room

Suppose you want to unpack a big box of medicines and repack in smaller packages for distribution. This involves opening the big box, counting each item, making smaller packs on a working table etc. This is a method involving multiple processes. You will have to validate this process to ensure that the medicine is not affected.

Conclusion: What is difference between Temperature qualification and validation

The above examples might have given you a good idea regarding the difference. We will conclude that a qualification process is only for a particular asset such as a cold room, warehouse, van, reefer, cold box etc. A validation involves certification of a set of processes when a parameter passes through different environments.

Pharma industry specifies to carry out temperature mapping study for all vans used for distribution of medicines vaccines etc. It is a mandatory requirement to store all such medicines under controlled temperatures such as 2 to 8 ° Centigrade or 15 to 25 ° Centigrade. If the temperature goes beyond these limits, the medicine loses its therapeutic values. Hence the pharma distributor has to always keep these medicines under the specified temperature.

These medicines are transported in temperature controlled vans. The final stage of the distribution to pharmacies is a very vulnerable phase. In order to prove that these vans always maintain the desired temperature, a temperature mapping study is mandatory.

Guidelines for mapping study of Vans

We are providing hereunder brief guidelines on carrying out a detailed temperature mapping study of vans.

The following are the required tests as part of the complete study:

Startup test to decide how long it will take to reach the desired temperature once the van is switched on. As an example, we may find out that it requires 40 minutes to stabilize between 2 to 8 ° Centigrade after switching on the vehicle. If so, the client has to write a SOP for their regular operation to indicate the same.

Testing under an empty condition to prove that the entire area has a uniform temperature for a specified duration.

Testing under a partially loaded condition (eg. 60%). This is to analyze whether all areas inside the van maintain the temperature within limits during the entire tests.

Testing under fully loaded condition. This is to prove that the van maintains the correct perform even when the van has a full load.

Guidelines for duration of the mapping study of Vans

We generally recommend the following timelines for the different tests:

For deciding the type of tests and the duration of tests, we conduct details of applications from the client. All these details will be different based on the usage pattern of each client, country etc.After collecting all the relevant details, a protocol for temperature mapping study of the vans will be written.

Contents of temperature mapping study report

The report of a van will have following details:

All the individual readings from all the data loggers.

Detailed chart analysis of all test data.

MKT values of each test. This is only for understanding, and not for evaluation of the results.

Recommendations to include in the Standard operating procedure (SOP) of the client for the vans.

Hot and cold points for fixing the temperature sensors.

Preparation for mapping study of Vans

The performance of cooling units of vans is always a challenge. We strongly recommend to our clients for proper servicing of the vehicle and the cooling units before carrying out the tests. Also, it is beneficial to have a thorough check of the controller of the cooling unit. Such preparatory checks will reduce chances of failure of the vehicle.

India is a very large country with many cities. There are various kinds of businesses going around that involves warehouses, vans, trucks, reefers, refrigerators etc. There are also many businesses related to pharmaceutical industries. Temperature mapping study is one of the most important parts of such businesses.

Vacker Global provides the most authentic temperature mapping study service in various cities of India. We provide temperature mapping study services for all kinds of warehouses, pharmaceuticals indsutries, reefer vans etc.

VackerUAE monitoring is one of the leading companies in the GCC region that provides expertise in cold chain monitoring systems and products. Cold chain management involves the proper management and storage of goods and products that are sensitive to temperature. Cold chain monitoring includes handling of products like vegetables, dairy products, vaccines, medicines, etc. Since the quality and efficiency of such products is vastly affected by a temperature change, it becomes important to record the temperature and humidity of various modes it passes through to reach the customers. VackerUAE supplies a wide range of monitoring solutions for cold chain monitoring. Some of our products and services are described below:

Temperature recorder with printer for vehicles

This monitoring system is specially designed to keep track of the temperature inside the vehicles while goods are being transported. The device can show the current reading digitally and comes with an alert system to alert the user if the temperature exceeds more than the permitted level. The temperature limit in the device can be set manually by the user. The device is equipped with two sensors that remain connected with the refrigerated compartment of the vehicle which keeps track of temperature for every second. The recorded data can easily be printed out with the help of the printer attached to the device.

Temperature tracking system for vehicles, vans and trucks

Many temperature-sensitive products are carried in vans, trucks and other types of vehicles. These vans, trucks etc. have a special compartment that is refrigerated to keep the products safe during transportation. The system makes use of Global Positioning system (GPS) and GPRS. The GPS system keeps track of the location of vehicles and the device records the temperature. This helps to draw a relation between the variations of temperature in the refrigerated compartment of the vehicle according to the location. The device can also keep track of humidity inside the compartment. The user can also add an alert system which can alert the user with a phone call, SMS and Email if the temperature or humidity goes out of range of the desired level. All the alert systems in the device are optional.

What is the main difference between GPRS and GPS temperature monitoring?

Well, this is an obvious question in which many people ponder upon. In a GPS system, the system is capable of only tracking the vehicle and is not capable of transmitting any other data to the server. While a GPRS system uses a Sim Card that allows the recorded data be transmitted to the server. Generally, a GPRS system is much more expensive than GPS system due to internet data usage.

SMS temperature tracking for long haul trucks

VackerUAE provides the most economic temperature tracking systems for long-haul trucks using the GPRS system. With the installation of this system, the customer will receive the temperature condition of the refrigerated compartment every hour. The system will automatically send SMS to three mobile numbers used by operators. The system does not consist of any extra charges and the charge is only for the SMS. If the vehicle is moving far away or to other countries then a card with roaming card can be used which makes it possible for the user to keep track of vehicles even in the foreign countries.

Temperature data logger with printer

This device can be considered as a thermometer that has the capability to print out the readings. The device is used generally for the transportation of products such as medicines. The data logger (Read more on Data Loggers) is very easy to use and the recorded data from the data logger can be printed out without the help of any computer.

Temperature is an important part of the environment. Temperature has a large effect on human life as well as the environment. Temperature also can affect various products and properties. The right level of temperature is required for comfortable living. Temperature also can affect the qualities of various kinds of products hence it is necessary to monitor temperature continuously.

GCC is a group of countries with very hot climate. The GCC nations include Oman, United Arab Emirates, Kuwait, Kingdom of Saudi Arabia, Bahrain and Qatar. The natural climate of these countries does not allow the people in the country to live comfortably. Hence, artificial ways of managing temperature are very important for these countries. These countries generally have automated HVAC system installed. Temperature monitoring system makes it possible to maintain the temperature of a place automatically. The environment of GCC nations are far more hostile in terms of temperature than other parts of the world hence temperature monitoring is more important for these countries comparatively.

Temperature monitoring is especially important for food industries, cold rooms, warehouses, data centers, clean rooms, server rooms, health care industries, pharmaceutical industries, laboratories, etc. The environmental parameters of these places need to be strictly controlled to maintain the overall required standard as per international and local law.

Due to the hot and humid condition of the locations protection of temperature-sensitive products is also a challenging thing. The maintenance of the quality of products such as fresh fruits, milk, medicine, vaccines is highly challenging in the climate of GCC nations. Without the continuous monitoring of temperature in the storage of these products, maintaining the quality is almost impossible. Temperature monitoring has helped to live a comfortable life and protect products worth millions of dollars.

Various types of temperature monitoring system

Below listed are the different types of Temperature Monitoring Systems:

Temperature monitoring system for HVAC system in residential homes

GCC nations generally tend to have temperature in the higher side and effective HVAC system is a must for residential homes. Temperature monitoring systems integrated with the HVAC system of residential homes create a comfortable living environment for the residents. Vacker Global has been supplying high quality temperature monitoring systems for millions of residential homes across the GCC nations.

Temperature monitoring for temperature mapping

Temperature mapping is one of the important processes that help to ensure the protection of quality of products during storage of transportation. The main goal of temperature mapping is the identification of hot spots in a place. Vacker Global supplies temperature monitoring systems for temperature mapping for all kinds of warehouses, server rooms, carrier vans, etc.

Temperature monitoring for cold rooms

Various kinds of products such as medicines, vaccines, meat, vegetables etc. are stored in a cold room. Monitoring temperature inside the cold rooms helps to ensure the temperature is well in the range of required temperature. Monitoring temperature helps in the protection of these kinds of products which quality can easily be compromised in high temperature. Our temperature monitoring systems for cold rooms can be connected to Wi-Fi which helps in monitoring the temperature from a remote place. Various kinds of alert system such as SMS, phone call, Email etc. can be installed in these monitoring systems as required by the user.

Temperature monitoring for hospitals

Hospitals are highly sensitive places as many people with compromised immune system come in hospitals. Improper temperature in hospitals can result in spreading of germs and uncomfortable living conditions for sick people. Without proper monitoring of temperature hospitals can be quite a dangerous places to stay. We provide high capacity temperature monitoring systems throughout the GCC nation for hospitals and other health care centers.

Temperature monitoring for clean rooms

Cleanrooms are places where every parameter inside the place is strictly controlled. Monitoring temperature is also an important part of cleanrooms. Vacker Global has been supplying temperature monitoring systems for pharmaceutical clean rooms, food processing clean room, laboratory clean rooms and much more.

VackerGlobal Thermal division has started supplying all types of monitoring systems and measuring instruments in the African region. VackerGlobal has been a major supplier of such systems across the Middle East region. With a new representative office in Kenya, Vacker now expands operations in the African region.

Monitoring Systems and Measurement Systems by Vacker in Africa

We are presently supplying the following products and services in Africa:

For all your requirements of remote temperature sensors, thermometers, temperature monitoring alert systems etc., please contact our representative at Kenya at Tel no: +254-20-5293767. Also, you may send us an email and we will contact you within one working day.

Also, we are looking for more partners and regional distributors in the African region. Please contact us in case your company is interested in becoming our associates.

Generally for pharmaceutical storage areas, the humidity should be below 65%. This has been a general rule for pharmaceutical warehouse, cold rooms etc. However recently, many authorities have started implementing the same for pharmaceutical retailers ie. local pharmacies.

Recommended humidity for pharmacy stores

Unless otherwise specified by any particular medicine manufacturer, the general recommended humidity is a maximum relative humidity of 65%. The humidity inside your pharmacy may depend on different parameters, but the external humidity is the main factor. If you are in a country having high humidity, it is only natural to have a higher humidity inside the store as well. In many Middle East countries, the humidity is high and the stores are air conditioned. Since the temperature inside the store is lower, it attracts more humidity into the store. In such cases the humidity goes to 75% to 80% RH. This is higher than recommended levels of most of the medicine manufacturers.

How to reduce humidity inside the pharmacy stores?

In order to reduce humidity in any closed area, we need to use a dehumidifier. Among the different available technologies, a portable condensation dehumidifier would be the most suitable for shops, offices, homes etc. Depending on the size of the pharmacy, you have to select a suitable model based on its performance capacity. The performance capacity of a dehumidifier is in liter per hour or liters per day. The bigger the store, you need a dehumidifier of higher capacity.

Installation of a dehumidifier inside your pharmacy is simple. These machines extract water form the air. We have to drain the water periodically either manually or by drainage pipe. If you do not have provision to connect a drainage pipe, there is a water tank in the dehumidifier. Water fills into the tank continuously. Once the tank is full, the dehumidifier stops automatically. Then someone has to drain the tank manually. For continuous operation, it is easy to connect a drainage pipe.

The customer can adjust the required humidity by means of a hygrostat in the dehumidifier. If you adjust the requried humidity to 55%, the machine will work continuously until the humidity level reaches 55% RH. Then the machine automatically stops. Once the humidity rises once again, the machine will once again start working automatically.

How to select the right dehumidifier for your stores?

Depending on the size of the store, we have to select a model with suitable capacity. You may use our free software for dehumidifier calculation capacity. the capacity selection also depends on the temperature of the pharmacy. For all pharmacies, the temperature has to be below 25 Deg C. The calculation sheet also takes care of the room temperature.

Hygrometer for pharmacy stores to measure humidity

In order to measure the current humidity, you will need a humidity meter known as hygrometer or thermo hygrometer. The meter indicates current temperature and humidity. This meter will only indicate the current readings and will not record the readings. This will help you to check the current humidity levels to ensure that the room maintains the correct levels. If you require recording of the temperature and humidity, you may have a look at our wireless continuous temperature and humidity recording systems with phone call & SMS alert.

This article relates to temperature mapping study carried out for warehouses, cold rooms, vans, reefers etc in pharmaceutical industry. As explained in our other pages on mapping study, the procedure is to collect temperature & humidity data for a period of time. We can carry out this data collection either using the normal data loggers or wireless data loggers. Please read more for the comparison of both methods.

However, the disadvantage is that we will come to know of the excursions only after a couple of weeks after completion of the data collection. After data collection, it may take a couple of weeks to analyse the data and inform of any excursions. Valuable time is lost in this process.

Mapping study using wireless data loggers

In the above context, we will explain the methodology of temperature mapping study and qualification using wireless data loggers. The entire procedure of placing the data loggers and collection of data is same in both the cases. However, in this case, we will place wireless data loggers, It is better to use radio frequency or Zigbee based wireless sensors since they do not require a separate power source. We will have numerous wireless sensors (transmitters) and few receivers. We have to place the wireless sensors across the entire area same as we do for normal data loggers. And we have to connect few receivers to receive the data from all these sensors.

The main advantage of using a wireless data logger system is that we can analyse the data while the test is being carried out. We can program alerts so that email or SMS alerts will be generated in case the temperature goes beyond the permitted limits. We can view the data through a local server as well as through the internet. The temperature mapping company can monitor the data remotely over the internet and can suggest any corrective actions immediately. Sometimes the corrective actions will be as simple as changing the temperature setting of a thermostat.

Thus, the client will be confident of the outcome during the course of the study. However, this method is costlier than using the normal data loggers, since wireless data loggers are costly. Also, it will require some more time to configure these data loggers before the commencement of the study.

Dehumidification in the food industry to preserve the quality of food, especially packaged foods. Also, the shelf life of processed food is reduced if moisture gets into the food. In modern plants, the processing machinery is capable of creating a vacuum during the process, preventing entry fo moisture. However, it is safer to reduce the moisture of the environment for any such applications.

Applications of dehumidifiers in food industry

Few of the applications of food dehumidifiers are as below.

During the process of confectionary and bakery items such as sweets, it is necessary to keep a low humidity level. During packing the items, if moisture enters into the packing, the life of the item is drastically reduced.

Processing and packaging of dates also require low humidity environment to keep the quality and to have a longer life.

In the processing plants of meat and poultry, condensation of air happens if the moisture content is high. This will affect the machinery as well as the quality of the process. Hence the standards including HACCP standards recommend low humidity levels. We recommend condensation dehumidifiers for meat processing and poultry processing industries.

Reducing the humidity can lower the frost and ice formation on the stored goods.

During the manufacture of chocolate also, the moisture should be very low up to the wrapping process. As you can imagine, if the chocolate absorbs moisture before individual wrapping, the chocolate will be spoilt in a couple of days. So chocolate factories definitely require dehumidifiers.

Which types of dehumidifiers to use in the food industry?

The major types of dehumidifiers are just processing the internal air and recirculating. In such cases, there will not be any fresh air intake from outside. There are types which take fresh air from outside and process before passing into the food processing area. If you are using such a machine, you will need additional filters before the air intake to ensure the quality of the air which comes into the processing area.

By way of operation, there are two types of dehumidifiers viz. condensation dehumidifiers and desiccant dehumidifiers. Generally for a low-temperature application we use desiccant dehumidifiers (Typically below 10°C). For all applications above 10°C, we can consider condensation dehumidifiers. However, this is only a general guideline and please contact us for a free evaluation.

Reduce Frost and ice formation on stored goods

The food industry involves cold rooms, walk-in freezers, ultra low freezers etc. In all such cases, frost and ice formation happen on the stored goods. This is due to the solidification of the moisture particles. This causes inconvenience to the operators, increase the energy cost etc. A dehumidifier can drastically reduce this problem by reducing the moisture content in the air.

Reduce defrost cycle of cooling units

As you may know, the cooling units in the cold room and walk-in freezers go into defrost cycles, a couple of times a day. This is to defrost the ice, failing which the machine may fail causing internal damage. By reducing the moisture in the air, it is possible to reduce the defrost cycle, thus saving energy cost as well.